FDA.report

KLARITY MEDICAL

Primary DI
00817355024045
Brand
KLARITY MEDICAL
Company
KLARITY MEDICAL PRODUCTS, LLC
Model
R630-TPM
Device description
Hand Grips With Metal Screws for Optek Board, Each of 2 pcs.
Published
2019-07-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications

CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817355024045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817355024045008173550240458173550240450817355024045

GMDN Terms

TermDefinition
Indexed-immobilization patient positioning systemA assembly of devices used primarily in radiation therapy applications, and consisting of an indexed treatment or imaging table (couch) that contains locking interfaces used to attach various positioning and immobilization devices to numbered or lettered (indexing) points on the table. It is used to ensure both adequate positioning and immobilization of a patient and to help ensure reproducible alignment between a target portion of the patient's anatomy and the radiation beams or fields used in radiation therapy treatments, diagnostic imaging studies. It may accommodate a variety of anatomically targeted patient positioning and immobilization attachments.

Sterilization Methods

Method

Regulatory Flags

DUNS number
034824691
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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00840510401108KLARITY MEDICALR7512-70C2026-03-23
00840510401115KLARITY MEDICALR7512-50C2026-03-23
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00840510401139KLARITY MEDICALR7512-47C2026-03-23
00817355025394KLARITY MEDICALR421U2025-10-30
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00817355028111KLARITY MEDICALRE-630ESCF2026-03-13
00817355025806KLARITY MEDICALPS-2022A2026-03-12
00817355025820KLARITY MEDICALPS-3200A2026-03-12
00817355025868KLARITY MEDICALPS-3201A2026-03-12
00817355026247KLARITY MEDICALPS-2400A2026-03-12
00840510401054KLARITY MEDICALGR7504-A30C2026-03-12
00840510401061KLARITY MEDICALRG-BHS-A2436F2026-03-12
00840510401078KLARITY MEDICALRG-BHS-8A24362026-03-12
00817355025622KLARITY MEDICALRE-7EC2022-01-05
00817355021976KLARITY MEDICALP-3201A2026-03-06
00817355025790KLARITY MEDICALPB-2412A2026-03-06
00817355025813KLARITY MEDICALP-3205A2026-03-06

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